Kornimate/medical-research-clean huggingface dataset:
austrian registry on the outcome of monochorionic pregnancies

Conditions: Twin Dichorionic Diamniotic Placenta; Twin Monochorionic Monoamniotic Placenta; Twin-To-Twin Transfusion Syndrome; Twin Pregnancy With Antenatal Problem

Summary: about one third of twin pregnancies are resulting from a single fertilized oocyte. two third of these monozygotic twins share a common placenta and are therefore called monochorionic. due to placental sharing and the ever-present inter-fetal vascular connections, specific complications may arise and lead to an increased risk of intrauterine death and long-term neurodevelopmental impairment. specific complications include twin-to-twin transfusion syndrome (ttts), twin-anemia-polycythemia sequence (taps), selective intrauterine growth restriction (siugr) and discordant major anomalies, occurring in about 10%, 5%, 20% and 6% of monochorionic diamniotic twins. prenatal interventions may improve perinatal and long-term outcome of affected fetuses. however, general knowledge about early diagnosis of monochorionic twins and their specific complications is still limited in a significant number of practitioners in austria and systematic analysis of pregnancy outcomes are not conducted. in this prospective multicenter registry study, the investigators aim to include all monochorionic pregnancies in austria. main outcome parameter is the occurrence of complications. secondary outcomes are gestational age at occurrence of complications, gestational age delivery and neonatal outcome. the investigators also strive for long-term outcome, especially of infants following complicated pregnancies or preterm birth.


Eligibility criteria:
inclusion criteria: * all monochorionic pregnancies diagnosed from 11+0 weeks of gestation exclusion criteria: * dichorionic twin pregnancies or higher-grade multiples without a monochorionic pair
a phase i/ii study of recombinant human gm-csf in patients with aids virus infection and leukopenia

Conditions: HIV Infections; Cytopenias

Summary: to determine the maximum tolerated dose (mtd) and toxicity of sargramostim (recombinant granulocyte-macrophage colony-stimulating factor; gm-csf) given by continuous intravenous infusion (civ) in patients with leukopenia in association with aids virus infection. in addition, single dose and steady state pharmacokinetics will also be determined.


Eligibility criteria:
inclusion criteria patients must have: * met the cdc criteria for the diagnosis of aids. * total peripheral blood leukocyte count = or \< 3000 cells/mm3 measured on at least two occasions separated by a minimum of one week. * must have or have recovered from one or more opportunistic infection. * serum antibody to htlv-iii/lav with or without viremia. * anticipated survival of at least 6 months. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * aids related complex (arc). * history of malignancy other than kaposi's sarcoma (ks). * excessive diarrhea (more than 5 liquid or non-liquid stools per day). * currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infections. * presence of renal dysfunction. * other evidence of primary hematologic or infectious disorders unrelated to aids virus infection. patients with the following are excluded: * aids related complex (arc). * history of malignancy other than kaposi's sarcoma (ks). * excessive diarrhea (more than 5 liquid or non-liquid stools per day). * currently hospitalized or hospitalized within the last 4 weeks for the treatment of an opportunistic infection. * dementia or altered mental status that would prohibit the giving and understanding of informed consent. prior medication: excluded: * any marrow suppressive medications such as trimethoprim-sulfamethoxazole combination (tmp-purposex) or fansidar. * excluded within 6 weeks of study entry: * any investigational drug. prior treatment: excluded within 6 weeks of study entry: * systemic cytotoxic chemotherapy or irradiation. risk behavior: excluded within 3 months of study entry: * regular, excessive use of alcohol, hallucinogens or agents which are addicting.

Keywords: leukopenia drug evaluation granulocyte-macrophage colony-stimulating factor
g7 dual mobility system used in total hip arthroplasty for the treatment of femoral neck fracture

Conditions: Hip Fractures

Summary: this is a retrospective and prospective, multi-center, non-comparative, post market clinical follow-up study involving orthopedic surgeons skilled in tha and experienced implanting the devices included in this study.

the objectives of the study are to document the performance and safety of the g7 dual mobility system when used in primary total hip arthroplasty for the treatment of femoral neck fracture by analysis of standard scoring systems, radiographs, revision and adverse event records.the study will include a maximum of 15 centers and up to 300 implanted hips. each center may enroll up to a maximum of 40 hips to permit the consistency of outcomes across a variety of investigators and clinical setting

Eligibility criteria:
inclusion criteria: * 55 to 80 years of age, inclusive * skeletally mature * have undergo treatment or in need of primary tha treatment of non-union, femoral neck fracture, unmanageable by other techniques * have g7 dual mobility system implanted or decision to have a g7 dual mobility system implanted was made independently and prior to recruitment into study * willing and able to complete scheduled follow-up evaluations as described in the study protocol * has participated in the informed consent process and is willing and able to sign an irb/ec approved informed consent exclusion criteria: * is septic, has an active infection or has osteomyelitis at the affected joint * has significant osteoporosis as defined by treating surgeon * has metabolic disorder(s) which may impair bone formation * has osteomalacia * has distant foci of infections which may spread to the implant site * has rapid joint destruction, marked bone loss or bone resorption on pre-operative radiographs * has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery * has any concomitant disease which is likely to jeopardize the functioning or success of the implant * is known to be pregnant * is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails * has a known sensitively or allergy to one or more of
the effect of pre-anesthetic education on cardiac surgery patients' anxiety level

Conditions: Cardiac Surgery Patients

Summary: the study aims to investigate the effect of pre-anesthetic education on patients undergoing cardiac surgery

approval from ethical committee of faculty of medicine university of indonesia was acquired prior conducting the study. subjects were given informed consent before enrolling the study. subjects identification was done using identification form, medical record, mini mental state evaluation (mmse) and internal classification of diseases (icd) 10. subjects' anxiety level were measured using amsterdam preoperative anxiety and information scale (apais) with the help of the researcher to explain the questions. then, education were given to the subjects, guided by a flow chart made by the researcher, using verbal and emphatic non-verbal language. if during education subjects got anxious with or without cardiovascular emergencies, education would be stopped, subjects would be eased down. subject's family would be called in. if the subjects agreed to continue, the study would be carried on, otherwise subjects were dropped out. benzodiazepin and midazolam 0.5 mg/kgbw would be considered and consulted to a psychiatrist. on the day after the education and discussion, subjects filled in apais again before entering the operation room. apais score recorded before and after anesthesia would be presented in the means, and analyzed by spss using paired t-test (or wilcoxon test as the alternative test).

Eligibility criteria:
inclusion criteria: * subjects aged 18-65 years old * subjects able to read and write properly * subjects have adequate communication ability * subjects were able to speak indonesian language properly * subjects were planned to undergo cardiac surgery * subjects have given informed consent for the anesthetical and surgical procedures. exclusion criteria: * subjects who did not give informed consent * subjects who had done a cardiac surgery before this study commenced, * subjects who had a cognitive/psychiatric problem that decreased communication ability * subjects in antianxiety and/or antidepressant treatment. drop out criteria: * subjects who had anxiety sign and symptoms with/without cardiovascular alarming signs and could not be eased down during education * subjects decided to drop out the study.

Keywords: cardiac surgery, anxiety, education
phase 4 study to assess the safety of vivotif at different release titers among travelers

Conditions: Typhoid Fever

Summary: this is a multicenter (at travel clinics), phase 4 observational prospective cohort study in healthy adult male and female travelers for whom typhoid vaccination with vivotif is recommended, as per standard practice.

this is a multicenter (at travel clinics), phase 4 observational prospective cohort study in healthy adult male and female travelers for whom typhoid vaccination with vivotif is recommended, as per standard practice. the study will enroll 950 subjects who will be randomized at a ratio of 1:1 into two groups, a and b, of 475 subjects each. group a will receive 6.9-10.0 x109 cfu/capsule and group b will receive 4.0-6.8 x109 cfu/capsule, respectively. all subjects will receive four doses of vivotif. one dose per subject will be administered on days 1, 3, 5 and 7. investigators, subjects and all personnel involved in running the study will not be aware of the actual release titer associated with the distributed lots. blinding is maintained using the commercial packaging that does not include the actual value of the release titer.

Eligibility criteria:
inclusion criteria: 1. subjects are male or female aged ≥ 18 years at time of dosing 2. subjects are travelers attending travelers' vaccination clinics 3. subjects are eligible for typhoid vaccination, according to standard practice 4. subjects are expected to be able to provide follow-up information 5. subjects have an expected travel departure date more than 21 days after enrollment (to enhance follow-up by ensuring subjects remain in the us during the ae collection period) 6. subjects must sign a written informed consent exclusion criteria: 1. subjects with a known hypersensitivity to any component of the vaccine or the enteric coated capsule 2. subjects deficient in their ability to mount a humoral or cell-mediated immune response due to either a congenital or acquired immunodeficient state including treatment with immune-suppressive or antimitotic drugs 3. subjects with an acute febrile illness 4. subjects with acute gastrointestinal (gi) illness 5. subjects who are receiving medications with antibacterial activity (including proguanil) at the time of enrollment 6. subjects with other contraindications as determined by the site investigator

Keywords: vaccine
to evaluate the paediatric analgesia slide

Conditions: Pain

Summary: the paediatric analgesia slide is a device developed for parents. its development follows research into the paediatric analgesia wheel, a device intended for use by hospital doctors. previous research has shown the benefit of using aids such as the paediatric analgesia wheel when simulating prescribing to children in hospital. at present, it is unknown whether this concept can be extended to use by parents when administering paracetamol to their children at home.

prescribing and administering drugs to children is difficult for both healthcare professionals and parents. the process is often performed poorly with under-dosing and over-dosing a major problem with sometimes fatal consequences. the british national formulary for children (bnfc), introduced in 2005, has given hospital and community prescribers with a valuable reference text. however, the comprehensive prescribing information presented in the bnfc and in the drug summary of product characteristics is simplified in the patient information leaflet (pil) for interpretation by parents. when the pil is analysed, it becomes apparent that the age-range regimens presented may result in under and over-dosing with large differences in the daily dose received by children depending on their age and weight. the paediatric analgesia slide is a simple device presenting pre-calculated volume (and therefore dose) information for parents. it allows for age/weight specific doses to be given thus minimising the risk of under and over-dosing. it also addresses the deficiency of the prescribing information in the pil related to over and under-weight children.

Eligibility criteria:
inclusion criteria: * any parent accompanying their child who is aged between 1 and 13 years old who is attending a hospital in county durham and darlington acute hospitals nhs trust exclusion criteria: * those who have professional knowledge of prescribing or dispensing medicine (e.g. as a doctor, nurse or pharmacist); * those who already have been given advice on the correct dose of paracetamol for their child as part of the current hospital episode; * those who's child is under 1 year or over 13 years old and; * those who have participated in this research before.

Keywords: paediatric analgesic prescribing parents
treatment of vasopressor-induced ischemia with botulinum toxin a

Conditions: Ischemia; Vasopressor

Summary: the goal of this project is to determine if performing a "chemical sympathectomy" by injecting botulinum toxin a in critically ill patients on vasopressors can treat digital ischemia. this is a prospective, non-randomized pilot study designed to demonstrate proof of concept. we propose to study patients in the intensive care units of duke hospital who, secondary to exposure to vasoactive medications used to maintain acceptable blood pressures, have developed signs and symptoms of digital ischemia. a paired t-test will be used to compare pre- and post-injection laser doppler measurements for the experimental hand. we will again use a paired t-test to compare the experimental hand against the contralateral control hand. there were no major adverse events reported by the product information sheet or in other related studies of botox for digital ischemia.


Eligibility criteria:
inclusion criteria: * be admitted to the icu * have digital ischemia and * be on a vasopressor infusion exclusion criteria: * patients with a history of systemic sclerosis * patients actively receiving aminoglycoside antibiotics - aminoglycosides may potentiate the effect of botox * patients who have previously received botulinum toxin (a or b) injections * patients with a history of disorders of neuromuscular transmission (e.g myasthenia gravis, lambert-eaton, etc.) - botox may have a lasting effect in these patients given their disorder * patients with clinical evidence of an infection in either forearm or hand * patients with a history of sensitivity to albumin - botox is sold in powder form and there is albumin in the formulation * pregnancy - botox is a class c medication * rheumatoid arthritis * upper extremity arterio-venous graft or fistula * digital necrosis * history of hand amputation * patients whom the intensive care attending physician deems will expire within 48 hours

Keywords: digital ischemia vasopressor
a machine learning algorithm to predict health clinical situations in primary healthcare for frail older adults.

Conditions: Frail Elderly Syndrome

Summary: introduction: we developed a machine learning algorithm to predict the risk of emergency hospitalization within the new 7 to 14 days with a good predictive performance (auc=0.85). data recorded by home aides were send in real time to a secure server to be analyzed by our machine learning algorithm, which predicted risk level and displayed it on a secure web-based medical device. this study aims to implement and to evaluate the sensitivity and specificity's predictions of presage system for four clinical situations with a high impact on unscheduled hospitalization of older adults living at home: falls, risk of depression (is sadder), risk of undernutrition (eat less well) and risk of heart failure (swollen leg). methods this is a retrospective observational multicenter study. to gain insight on both short-and middle-term predictions and how the risk factors evolve through different periods of observation, we developed a series of models which predict the risk of future clinical symptoms.

this is a retrospective observational multicenter study. this study was conducted on two distinct cohorts. data between january 2020 - february 2023 from 50 home care facilities using presaege care medical device on a daily basis were analyzed. 740 853 data from 27 439 visits by home aides for 1 478 patients. the patients' mean age was 84,89 years (sd = 8.9 years) with a moderate dependency level and the sample included 1 038 women (70%). presage care is a medical device ce marked to predict emergency hospitalizations. this e-health system is based on a questionnaire focused on functional and clinical autonomy (ie, activities of daily life), possible medical symptoms (eg, fatigue, falls, and pain), changes in behavior (eg, recognition and aggressiveness), and communication with the ha or their surroundings. based on these data, some others risks are evaluated and predict by the artificial intelligence algorithm. this study aims to evaluate the sensitivity and specificity's predictions of presage care system for four clinical situations with a high impact on unscheduled hospitalization of olders adults living at home: falls, risk of depression (is sadder), risk if (eat less well) and risk of heart failure (swollen leg). the principal objective was the sensitivity and specificity of four events' prediction: falls, "is sadder", "eat less well" and "swollen leg" for non-tautological events (when events no appear in the observation window). secondary objective was the sensitivity and specificity of four events' prediction: falls, "is sadder", "eat less well" and "swollen leg" for tautological events (when events appear in the observation window).

Eligibility criteria:
inclusion criteria: * frail older adults aged 65 years old and over * receive the help of a home care aide using presage care * all eligible persons were invited to participate and were included if they provided consent

Keywords: frailty older adults artificial intelligence falls undernutrition depression heart failure risk
microfluidics versus density gradient centrifugation for sperm preparation in ivf

Conditions: Male Infertility; Sperm DNA Fragmentation; In Vitro Fertilization (IVF)

Summary: this randomized controlled trial aimed to compare the effectiveness of microfluidic sperm sorting and density gradient centrifugation (dgc) in reducing sperm dna fragmentation index (dfi) and improving clinical outcomes in ivf. a total of 119 couples underwent ivf and were assigned to either microfluidic or dgc sperm preparation. the study evaluated sperm quality, fertilization, embryo development, and live birth rates.

this single-center randomized controlled trial was conducted at hanoi medical university hospital from march 2023 to march 2024. couples undergoing ivf were randomized to two sperm preparation methods: microfluidics or density gradient centrifugation. sperm dna fragmentation index (dfi) was assessed before and after preparation. primary outcomes included live birth rate and dfi reduction; secondary outcomes included sperm motility and morphology, fertilization rate, embryo quality, and pregnancy outcomes. the study received irb approval and adhered to ethical standards.

Eligibility criteria:
inclusion criteria: * female partner aged between 18 and 40 years * couples undergoing in vitro fertilization (ivf) cycles at the ivf and tissue engineering center, hanoi medical university, between january 2022 and january 2024 * use of autologous oocytes * use of ejaculated sperm * both partners provide written informed consent exclusion criteria: * use of donor oocytes or donor sperm * requirement for testicular sperm extraction * diagnosis of oligoasthenozoospermia (oa) based on who 2021 criteria * female partner classified as having poor ovarian prognosis according to the poseidon 2016 criteria, including: * anti-müllerian hormone (amh) level \< 1.2 ng/ml * antral follicle count (afc) \< 5 * or history of poor ovarian response (≤9 oocytes retrieved in previous cycles) * preimplantation genetic testing (pgt) cycles

Keywords: microfluidics sperm dna fragmentation in vitro fertilization sperm preparation icsi
understanding the measurement of girdle dissociation in the fall of the older people subject.

Conditions: Fall Patients; Frailty

Summary: falls, especially in the older people, are frequent with potential serious consequences. the strategy for preventing falls involves detecting the fall risk. current tests to determine the risk of falling are too late indicators of gait disorder. loss of gait dissociation is an element associated with the mechanism of the fall and appears earlier. its diagnosis is particularly important as it is a reversible impairment if rehabilitation interventions can be proposed to correct this anomaly.

the purpose of this study is to validate the device's measurement of belt dissociation in a discriminating manner between fallers and nonfallers.

Eligibility criteria:
inclusion criteria: * informed and signed a written consent form. * affiliated or eligible to a health insurance system. * being able to give their consent to participate. * for fallers: had at least one fall in the previous year. * for non fallers: not had a fall in the previous year. exclusion criteria: * patients suffering from a neurological or articular pathology responsible for gait disorders (parkinson's disease, hemiplegia, narrow lumbar canal, peripheral neuropathy, vestibular pathology, chronic inflammatory rheumatism...). * patients who have undergone joint surgery of the lower limbs during the year. * patients walking with a walker. * patients with an internal electronic device (pacemaker, neurostimulator, insulin pump...). * patients taking long-term neuroleptics. * patients with advanced major cognitive impairment (according to the clinical dementia rating protocol \>1).

Keywords: fall prevention older inertial sensors dissociation of girdles
an observational study of adherence to anastrozole in early breast cancer treatment

Conditions: Breast Cancer

Summary: the purpose of this study is to describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes) and estimate the proportion of postmenopausal women with early breast cancer who continue anastrozole therapy after one year follow-up.


Eligibility criteria:
inclusion criteria: * postmenopausal woman with early breast cancer who are prescribed with anastrozole as adjuvant endocrine therapy under the routine clinical practice. * histologically or cytologically proven to be hr+(er or pr +) * no other concomitant endocrine therapy such as estrogen therapy or selective estrogen receptor modulators * provision of written informed consent exclusion criteria: * recurrence of breast cancer * known hypersensitivity to anastrozole or to any of its excipients * any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize adherence with the trial protocol: amenorrhea\<12 months and a intact uterus; previous inclusion in the present study; participation in a other clinical study during the last 30 days· * women who does not agreed to participate the program

Keywords: breast cancer adherence anastrozole post-menopausal women